Predictive Low Glucose Suspend Research Articles

MiniMed 780GTM in children with type 1 diabetes under seven years of age: Prospective open-label, single-arm, double-center, follow-up study.

Given the steadily rising incidence of type 1 diabetes (T1D), particularly among the youngest preschool children, coupled with well-documented challenges of achieving and maintaining optimal metabolic control in this age group, there is a growing need for advanced technological devices. To evaluate glycaemic control in children below the age of seven with type 1 diabetes (T1D) and assess the safety of the advanced hybrid closed loop (AHCL) system in comparison to the previous treatment method, a sensor-augmented pump with predictive low-glucose suspend (SAP-PLGS). Data from 10 children (aged 2.60-6.98 years) with T1D who transitioned to the AHCL system from SAP-PLGS were analysed. SAP-PLGS records from two weeks prior to the initiation of AHCL were compared with records from the initial four weeks post-switch (excluding the training period). These data were examined at two 2-week intervals and compared with records from two weeks post six-month usage of the AHCL. A significant decrease in the average nighttime glucose concentration was observed compared to pre-AHCL values (p= 0.001, concordance W = 0.53). The Glucose Management Indicator (GMI) value significantly decreased from 6.88 ± 0.37% to 6.52 ± 0.32% (p= 0.018, rbc = 0.93) immediately following the device switch and stabilized at 6.50 ± 0.28% (p= 0.001, W = 0.53) and 6.55 ± 0.41% (p= 0.001, W = 0.53) at subsequent stages of the study. An improvement was also observed in mean glucose values for time spent < 54 mg/dl, while the proportion of time within this range was maintained, both during the day (p< 0.001, W = 0.58) and at night (p= 0.002, W = 0.83). The AHCL MiniMed 780GTM system improved glycaemic control in the studied group of children under seven years of age with T1D compared to previous SAP-PLGS therapy. It proved to be safe for delivering insulin in this age group.

Factors affecting the prolongation of glycemic time in range among children with type 1 diabetes using continuous glucose monitoring systems: A case control study

Abstract Background Time in range is a reliable measure of the risk of diabetes complications. High percentage of patients with diabetes fail to achieve the recommended time in range (TIR) target of 70–180 mg/dl (3.9–10 mmol/l) &gt;70%. Objective This study aimed to identify factors influencing TIR prolongation. Methods Children aged 1–17 years with &gt;1-year type 1 diabetes (T1D) duration, treated with continuous subcutaneous insulin infusion (CSII) ≥3 months, using continuous glucose monitoring (CGM) or intermittently scanned CGM (is-CGM) ≥1 month, and with a registration time &gt;70% were included. Data were collected during routine diabetology visits at an outpatient clinic. Insulin pump and CGM or is-CGM reports in the most recent 14 days were recorded using a dedicated software. Legal caregivers were also asked to complete a questionnaire on how the patients use the insulin pump functions and eating habits. Results A sample of 110 patients was categorized into two groups: those with TIR &gt;70% and TIR ≤70%. TIR ≤70% group presented with repeated hyperglycemia and a high glycemic variability coefficient of variation. We noted an acceptable hypoglycemia rate (3%), regardless of the TIR value. Patients with TIR &gt;70% predominantly used predictive low glucose suspend system, maintained adequate intervals between insulin delivery and meal consumption, used the “bolus calculator” function, and more frequently created electronic reports. Conclusions Hyperglycemia and high glycemic variability prevent patients from achieving the target TIR. Advanced features in the CGM systems, premeal insulin bolus, and patients’ involvement in diabetes treatment are the main factors contributing to TIR prolongation.

Daytime hypoglycemic episodes during the use of an advanced hybrid closed loop system

AimsThe use of advanced hybrid closed loop systems is spreading due to the beneficial effects on glycometabolic control obtained in patients with type 1 diabetes. However, hypoglycemic episodes can be sometimes a matter of concern. We aim to compare the hypoglycemic risk of an advanced hybrid closed loop system and a predictive low glucose suspend sensor augmented pump. MethodsIn this retrospective three months observational study, we included 30 patients using Medtronic Minimed™ 780G advanced hybrid closed loop system and 30 patients using a Medtronic Minimed™ predictive low glucose suspend sensor augmented pump. ResultsThe advanced hybrid closed loop system reduced the time spent above 180 mg/dL threshold and increased the time in range as compared to the predictive low glucose suspend. No severe hypoglycemia occurred in both groups and no differences were observed in the percentage of time spent below 70 mg/dl and 54 mg/dl glucose threshold. Nevertheless, more hypoglycemic episodes were recorded during daytime, but not in nighttime, with the use of the advanced hybrid closed loop system. ConclusionsOur results confirmed the general improvement of glycemic outcomes obtained with the advanced hybrid closed loop system; however more hypoglycemic episodes during daytime were evident.

The Tandem Control-IQ advanced hybrid system improves glycemic control in children under 18 years of age with type 1 diabetes and night rest in caregivers

ObjectiveTo determine the impact of switching from the predictive low glucose suspend (PLGS) system to the advanced hybrid Tandem Control-IQ system on glucometrics and glycosylated haemoglobin (HbA1c) at one year. To assess the impact on the quality of life perceived by parents. MethodProspective study in 71 patients aged 6–18 years with type 1 diabetes (DM1), in treatment with PLGS, who switched to an advanced hybrid system. Glucometric data were collected before the change, at 4 and 8 weeks, and at one year of use; HbA1c before the change and after one year. The Diabetes Impact and Devices Satisfaction (DIDS) questionnaire was used at weeks 4 and 8. ResultsAn increase in time in range (TIR) was observed with a median of 76% (P<.001) at 4 weeks, which was maintained after one year (+8% in the total group). Overall, 73.24% of patients achieved a TIR above 70%. The subgroup with an initial TIR of less than 56% increased it by 14.4%. After one year there was a 0.3% reduction in HbA1c. Level 1 hypoglycaemia, level 1 and level 2 hyperglycaemia, mean glucose (GM) and coefficient of variation (CV) decreased.Auto mode stayed on 97% of the time and no dropouts occurred.Caregivers had a perception of better glycaemic control and less need to monitor blood glucose variations during the night. None of them would switch back to the previous system and they feel safe with the new system. ConclusionsThe Tandem Control-IQ advanced hybrid system was shown to be effective one year after its implementation with improvement in all glucometric parameters and HbA1c, as well as night-time rest in caregivers.

920-P: Effects of Hybrid Closed-Loop System on Glycemic Control and Psychological Aspects in Persons with Type 1 Diabetes Treated with Sensor-Augmented Pump—A Prospective Single-Center Observational Study

Introduction Since the Medtronic 770G hybrid closed-loop (HCL) system was approved in Japan in 2022, we evaluated the effects of the HCL system on glycemic control and psychological aspects in persons with type 1 diabetes mellitus (T1DM) treated with the Medtronic 640G predictive low glucose suspend (PLGS) system. Materials and Methods In a 3-month prospective observational study, 21 people with T1DM (mean age: 48.7 years; male: 5 people) treated with PLGS system were enrolled. The participants switched to the 770G system, where the algorithm maintains glucose levels at 120 mg/dl, and in 3 months the percentage of time in blood glucose range (TIR) 70-180 mg/dl and glycated hemoglobin level (HbA1c) were evaluated. Self-reported questionnaires were administered at baseline and in 3 months to assess their satisfaction, emotional distress, and quality of life (QoL), using Diabetes treatment satisfaction questionnaire status (DTSQs), Problem area in diabetes scale (PAID), and Diabetes therapy-related QoL (DTR-QoL), respectively. Results In 3 months, TIR increased from 63.2 ± 13.7% to 72.7 ± 11.1% (mean ± standard deviation) (P &amp;lt; 0.0005), whereas time above blood glucose range (TAR) 181-250 mg/dl decreased from 26.9 ± 9.1% to 19.7 ± 7.2 % (P &amp;lt; 0.0005). TAR &amp;gt; 250 mg/dl, time below blood glucose range (TBR) 54-69 mg/dl and TBR &amp;lt; 54 mg/dl did not differ significantly. HbA1c decreased from 7.7 ± 1.0% to 7.2 ± 0.8% (P = 0.0013). There were no significant changes in DTSQs, PAID, and DTR-QOL in 3 months (DTSQs 26.7 ± 6.0 compared with baseline 26.9 ± 4.0, P = 0.87, PAID 52.3 ± 17.9 compared with baseline 54.0 ± 16.3, P = 0.48, DTR-QoL 50.1 ± 19.0 compared with baseline 47.0 ± 16.9, P = 0.38). Conclusion HCL system could increase TIR, compared with PLGS system, without worsening treatment satisfaction, emotional distress, and QoL. This study suggested HCL system is useful for Japanese people with T1DM. Disclosure T. Akiyama: None. K. Orime: None. T. Yamakawa: None.

The impact of hybrid closed loop and predictive low-glucose suspend insulin pumps in the management of type 1 diabetes mellitus in children

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Effect of Sensor-Augmented Patch Pump with Predictive Low-Glucose Suspend Feature Compared to Multiple-Dose Insulin in Patients with Brittle Type 1 Diabetes

Effect of Sensor-Augmented Patch Pump with Predictive Low-Glucose Suspend Feature Compared to Multiple-Dose Insulin in Patients with Brittle Type 1 Diabetes

Switching to an advanced hybrid closed-loop system in real-world practice improves hypoglycemia awareness and metabolic control in adults with type 1 diabetes, particularly in those with impaired perception of hypoglycemia symptoms

AimsTo evaluate the efficacy of an advance closed-loop (AHCL) system in restoring awareness of hypoglycemia in patients with type 1 diabetes (T1D). MethodsWe conducted a prospective study including 46 subjects with T1D flash glucose monitoring (FGM) or continuous glucose monitoring (CGM) switching to a Minimed 780G® system. Patients were classified in three groups according to the therapy used before switching to Minimed® 780G: multiple dose insulin (MDI) therapy + FGM (n = 6), continuous subcutaneous insulin infusion + FGM (n = 21), and sensor-augmented pump with predictive low-glucose suspend (n = 19). FGM/CGM data were analyzed at baseline, after 2 and 6 months on AHCL. Clarke’s score of hypoglycemia awareness was compared at baseline and 6 months recordings. We also compared the efficacy of the AHCL system in improving A1c among patients with appropriate perception of symptoms of hypoglycemia compared to those presenting with impaired awareness of hypoglycemia (IAH). ResultsParticipants had a mean age of 37 ± 15 and a diabetes duration of 20 ± 10 years. At baseline, 12 patients (27%) showed IAH as defined by a Clarke’s score ≥ 3. Patients with IAH were older and had lower estimated glomerular filtration rate (eGFR) compared with those who did not have IAH; with no differences in baseline CGM metrics or A1c. An overall decrease in A1c was observed after 6 months on AHCL system (from 6.9 ± 0.5% to 6.7 ± 0.6%, P < 0.001), regardless of prior insulin therapy. The improvement in metabolic control was greater in patients with IAH, showing a reduction in A1c from 6.9 ± 0.5 to 6.4 ± 0.4% vs 6.9 ± 0.5 to 6.8 ± 0.6% (P = 0.003), showing a parallel increase in total daily boluses of insulin and automatic bolus correction administered by the AHCL system. In patients with IAH Clarke’s score decreased from 3.6 ± 0.8 at baseline to 1.9 ± 1.6 after 6 months (P < 0.001). After 6 months on AHCL system, only 3 patients (7%) presented with a Clarke’s score ≥ 3, resulting in an absolute risk reduction of 20% (95% confidence interval: 7–32) of having IAH. ConclusionsSwitching from any type of insulin administration to AHCL system improves restoration of hypoglycemia awareness and metabolic control in patients with T1D, particularly in adults with impaired perception of hypoglycemia symptoms. Trial RegistrationClinicalTrial.gov ID NCT04900636.

Hypoglycemia and glycemic variability of people with type 1 diabetes with lower and higher physical activity loads in free-living conditions using continuous subcutaneous insulin infusion with predictive low-glucose suspend system

IntroductionMaintaining glycemic control during and after physical activity (PA) is a major challenge in type 1 diabetes (T1D). This study compared the glycemic variability and exercise-related diabetic management strategies of...

The Medtronic 780G advanced hybrid closed-loop system achieves and maintains good glycaemic control in type 1 diabetes adults despite previous treatment

IntroductionImprovements in continuous glucose monitoring (CGM) in recent years have changed the treatment of type 1 diabetes (T1D) by permitting the automation of glucose control. The Minimed 780G advanced hybrid closed-loop (ACHL) system adapts basal infusion rates and delivers auto-correction boluses in order to achieve a user-decided glucose target (100, 110 or 120mg/dL). This study set out to evaluate the effectiveness of the Medtronic 780G system in real-life conditions over 6 months. Materials and methodsProspective study that included T1D subjects previously treated with insulin pump without CGM (pump group) or with sensor-augmented pump with predictive low-glucose suspend (SAP-PLGS group) who started with the Minimed 780G system. Sensor and pump data from baseline, and at 1, 3 and 6 months were downloaded and HbA1c was recorded at baseline and at 6 months. ResultsFifty T1D subjects were included; 25 were previous SAP-PLGS 640G users and 25 used 640G without CGM. 66% were female, 48.6 (40–57) years of age with 20 (12–31.5) years of diabetes duration. Time in range (TIR) improved in the total cohort from baseline to 6 months (69% (57.7–76) vs. 74% (70–82); p=0.01 as did HbA1c (7.6% (7.1–7.8) vs. 7.0% (6.8–7.5); p<0.001), with improvement in times <54, >180 and >250mg/dL. Outcomes at 6 months did not differ between groups, although the SAP-PLGS subjects were prone to hypoglycaemia and the pump group mainly presented suboptimal metabolic control. ConclusionThe AHCL Medtronic Minimed 780G system achieves and maintains good glycaemic control over 6 months in real-life conditions in different profiles of T1D subjects.

Update information on type 1 diabetes in children/adolescents and adults.

Update information on type 1 diabetes in children/adolescents and adults.

The Medtronic 780G advanced hybrid closed-loop system achieves and maintains good glycaemic control in type 1 diabetes adults despite previous treatment

IntroductionImprovements in continuous glucose monitoring (CGM) in recent years have changed the treatment of type 1 diabetes (T1D) by permitting the automation of glucose control. The Minimed 780G advanced hybrid closed-loop (ACHL) system adapts basal infusion rates and delivers auto-correction boluses in order to achieve a user-decided glucose target (100, 110 or 120mg/dL). This study set out to evaluate the effectiveness of the Medtronic 780G system in real-life conditions over 6 months. Materials and methodsProspective study that included T1D subjects previously treated with insulin pump without CGM (pump group) or with sensor-augmented pump with predictive low-glucose suspend (SAP-PLGS group) who started with the Minimed 780G system. Sensor and pump data from baseline, and at 1, 3 and 6 months were downloaded and HbA1c was recorded at baseline and at 6 months. ResultsFifty T1D subjects were included; 25 were previous SAP-PLGS 640G users and 25 used 640G without CGM. 66% were female, 48.6 (40–57) years of age with 20 (12–31.5) years of diabetes duration. Time in range (TIR) improved in the total cohort from baseline to 6 months (69% (57.7–76) vs. 74% (70–82); p=0.01 as did HbA1c (7.6% (7.1–7.8) vs. 7.0% (6.8–7.5); p<0.001), with improvement in times <54, >180 and >250mg/dL. Outcomes at 6 months did not differ between groups, although the SAP-PLGS subjects were prone to hypoglycaemia and the pump group mainly presented suboptimal metabolic control. ConclusionThe AHCL Medtronic Minimed 780G system achieves and maintains good glycaemic control over 6 months in real-life conditions in different profiles of T1D subjects.

A Multicenter Randomized Trial Evaluating the Insulin-Only Configuration of the Bionic Pancreas in Adults with Type 1 Diabetes.

Objective: To evaluate the insulin-only configuration of the iLet® bionic pancreas (BP) using insulin aspart or insulin lispro in adults with type 1 diabetes (T1D). Methods: In this multicenter, randomized, controlled trial, 161 adults with T1D (18-79 years old, baseline HbA1c 5.5%-13.1%, 32% using multiple daily injections, 27% using a pump without automation, 5% using a pump with predictive low glucose suspend, and 36% using a hybrid closed loop system before the study) were randomly assigned 2:1 to use the BP (N = 107) with insulin aspart or insulin lispro (BP group) or a standard-of-care (SC) control group (N = 54) using their usual insulin delivery plus continuous glucose monitoring (CGM). The primary outcome was HbA1c at 13 weeks. Results: Mean HbA1c decreased from 7.6% ± 1.2% at baseline to 7.1% ± 0.6% at 13 weeks with BP versus 7.6% ± 1.2% to 7.5% ± 0.9% with SC (adjusted difference = -0.5%, 95% confidence interval -0.6% to -0.3%, P < 0.001). Over 13 weeks, mean time in range 70-180 mg/dL (TIR) increased by 11% (2.6 h/d) and mean CGM glucose was reduced by 16 mg/dL with BP compared with SC (P < 0.001). Improvement in these metrics was seen during the first day of BP use and by the end of the first week reached levels that remained relatively stable through 13 weeks. Analyses of time >180 mg/dL, time >250 mg/dL, and standard deviation of CGM glucose all favored the BP group (P < 0.001). The CGM-measured hypoglycemia was low at baseline (median time <54 mg/dL of 0.21% [3 min/d] for the BP group and 0.11% [1.6 min/d] for the SC group) and not significantly different between groups over the 13 weeks (P = 0.51 for time <70 mg/dL and 0.33 for time <54 mg/dL). There were 7 (6.5% of 107 participants) severe hypoglycemic events in the BP group and 2 events in the SC group (1.9% of 54 participants, P = 0.40). Conclusions: In adults with T1D, use of the BP with insulin aspart or insulin lispro improved HbA1c, TIR, and hyperglycemic metrics without increasing CGM-measured hypoglycemia compared with standard of care. Clinical Trial Registry: clinicaltrials.gov; NCT04200313.

Biobehavioral Changes Following Transition to Automated Insulin Delivery: A Large Real-life Database Analysis.

To document glycemic and user-initiated bolus changes following transition from predictive low glucose suspend (PLGS) system to automated insulin delivery (AID) system during real-life use. We conducted analysis of 2,329,166 days (6,381 patient-years) of continuous glucose monitoring (CGM) and insulin therapy data for 19,354 individuals with type 1 Diabetes, during 1-month PLGS use (Basal-IQ technology) followed by 3-month AID use (Control-IQ technology). Baseline characteristics are as follows: 55.4% female, age (median/quartiles/range) 39/19-58/1-92 years, mean ± SD glucose management indicator (GMI) 7.5 ± 0.8. Primary outcome was time in target range (TIR) (70-180 mg/dL). Secondary outcomes included CGM-based glycemic control metrics and frequency of user-initiated boluses. Compared with PLGS, AID increased TIR on average from 58.4 to 70.5%. GMI and percent time above and below target range improved as well: from 7.5 to 7.1, 39.9 to 28.1%, and 1.66 to 1.46%, respectively; all P values <0.0001. Stratification of outcomes by age and baseline GMI revealed clinically significant differences. Glycemic improvements were most pronounced in those <18 years old (TIR improvement 14.0 percentage points) and those with baseline GMI >8.0 (TIR improvement 13.2 percentage points). User-initiated correction boluses decreased from 2.7 to 1.8 per day, while user-initiated meal boluses remained stable at 3.6 to 3.8 per day. Observed in real life of >19,000 individuals with type 1 diabetes, transitions from PLGS to AID resulted in improvement of all glycemic parameters, equivalent to improvements observed in randomized clinical trials, and reduced user-initiated boluses. However, glycemic and behavioral changes with AID use may differ greatly across different demographic and clinical groups.

Diabetestechnologie in der Schwangerschaft

The use of diabetes technology in pregnant women with type 1 diabetes, as well as in gestational diabetes and type 2 diabetes is becoming increasingly important. In the phase of increasing insulin resistance, especially in the second trimester, the focus is to adjust insulin therapy based on continuous glucose monitoring (CGM) targets. This requires proper bolus management and aggressive injection–eating intervals. In addition, it is essential that counseling have a strong focus on women’s eating behaviors, due to the high potential in terms of glycemic control. Sensor-augmented insulin pump therapy is used without trial data (low suspend, predictive low-glucose suspend, hybrid closed loop) and a few studies are expected to be undertaken in the near future, leaving observation as the only viable option for now. Artificial pancreas systems are the future, both in terms of control and well-being.

El sistema híbrido avanzado Tandem Control-IQ mejora el control glucémico en menores de 18 años con diabetes tipo 1 y el descanso nocturno de los cuidadores

ObjectiveTo determine the impact of switching from the predictive low glucose suspend (PLGS) system to the advanced hybrid Tandem Control-IQ system on glucometrics and glycosylated emoglobin (HbA1c) at one year. To assess the impact on the quality of life perceived by parents. MethodProspective study in 71 patients aged 6-18years with type 1 diabetes (DM1), in treatment with PLGS, who switched to an advanced hybrid system. Glucometric data were collected before the change, at 4 and 8weeks, and at one year of use; HbA1c before the change and after one year. The Diabetes Impact and Devices Satisfaction (DIDS) questionnaire was used at weeks 4 and 8. ResultsAn increase in time in range (TIR) was observed with a median of 76% (P<.001) at 4 weeks, which was maintained after one year (+8% in the total group). Overall, 73.24% of patients achieved a TIR above 70%. The subgroup with an initial TIR of less than 56% increased it by 14.4%. After one year there was a 0.3% reduction in HbA1c. Level1 hypoglycaemia, level1 and level2 hyperglycaemia, mean glucose (GM) and coefficient of variation (CV) decreased.Auto mode stayed on 97% of the time and no dropouts occurred.Caregivers had a perception of better glycaemic control and less need to monitor blood glucose variations during the night. None of them would switch back to the previous system and they feel safe with the new system. ConclusionsThe Tandem Control-IQ advanced hybrid system was shown to be effective one year after its implementation with improvement in all glucometric parameters and HbA1c, as well as night-time rest in caregivers.

Prospective Open-Label, Single-Arm, Single-Center Follow-Up Study of the Application of the Advanced Hybrid Closed Loop System in Well-Controlled Children and Adolescents with Type 1 Diabetes.

Background: The aim of this prospective open-label single-arm single-center follow-up study was to analyze glycemic control in children and adolescents with type 1 diabetes treated with the advanced hybrid closed loop (AHCL) system in relation to a sensor-augmented pump with low-glucose suspend (SAP-LGS) or predictive low-glucose suspend (SAP-PLGS). Materials and Methods: The data for 50 children and adolescents (age 5.5-19.6 years) with type 1 diabetes, receiving insulin through an AHCL system after being switched from SAP-LGS/PLGS systems, were included in the analysis. The SAP-LGS/PLGS records from 2 weeks preceding the AHCL connection were compared with the records from the first 4 weeks of AHCL use, represented as two separate 2-week intervals. Results: Significant improvements in most of the parameters, namely time spent in the range of 70-140 mg/dL (from 53.80% ± 12.35% to 61.70% ± 8.42%, P < 0.001) and 70-180 mg/dL (from 76.17% ± 10.28% to 81.32% ± 7.71%, P < 0.001), average sensor glucose (from 138.61 ± 16.66 to 130.02 ± 10.91 mg/dL, P < 0.001), and glucose management indicator (from 6.54% ± 0.45% to 6.27% ± 0.29%, P = 0.001), were observed within 2 weeks of switching to the AHCL. More evident improvements were observed for the parameters monitored at night than during the day. The potential limitations of this study were the short observation time, lack of glycated hemoglobin measurements, and no control arm. Conclusion: The AHCL system can significantly improve glycemic control even in well-controlled children and adolescents with type 1 diabetes by increasing the proportion of time spent in the narrower range of 70-140 mg/dL and decreasing the mean glucose concentration, especially during the night.

Sensor-Augmented Insulin Pump with Predictive Low-Glucose Suspend (PLGS): Determining Optimal Settings of Pump and Sensor in a Multicenter Cohort of Patients with Type 1 Diabetes.

IntroductionThe use of predictive low-glucose suspend (PLGS) sensor-augmented pumps has been shown to lead to a significant reduction in hypoglycemic episodes in patients with type 1 diabetes (T1D), but their effects on hyperglycemia exposure are heterogeneous. The aim of this study was to determine the settings of the Medtronic 640G system to obtain the optimal balance between occurrence of both hypoglycemia and hyperglycemia.MethodsThe hypo- and hyperglycemia area under the curve (AUC), as well as system settings [hypoglycemic threshold, mean insulin total daily dose (TDD), mean basal insulin percentage, and mean daily duration of PLGS] were collected between 2 and 12 times during 1 year in patients from four university hospital centers. Univariate/multivariate analyses and receiver operating characteristics (ROC) curves were performed to determine factors associated with hyper- and hypoglycemia AUC.ResultsA total of 864 observations were analyzed from 110 patients with T1D. Two preselected settings predictive of low hyperglycemia AUC were a basal insulin percentage < 52.0% [sensitivity (Se) = 0.66 and specificity (Sp) = 0.53] and a PLGS duration > 157.5 min/day (Se = 0.47 and Sp = 0.73). The preselected setting predictive of a low hypoglycemia AUC was a PLGS duration ≤ 174.4 min (Se = 0.83 and Sp = 0.51). Between-visit variation of PLGS and TDD was positively correlated (r = 0.61; p < 0.0001).ConclusionThe most important Medtronic 640G setting was the mean daily PLGS duration, where a value between 157.5 and 174.4 min/day was associated with the best reduction in both hypo- and hyperglycemia AUC. In this study, we showed that PLGS duration could be indirectly modified through total daily insulin dose adaptation.Trial Registration: This study is registered in clinicaltrials.gov (NCT 03047486).

Insulin settings and their association with time in range in patients with type 1 diabetes users of predictive low glucose suspend (PLGS) augmented insulin pumps in Santiago, Chile

AimsSensor augmented insulin pumps have become a powerful tool for managing type 1 diabetes (T1D). This study aimed to analyze the insulin pump configuration in users of predictive insulin suspension technology (PLGS). MethodsT1D patients on insulin pumps with PLGS (Medtronic 640G®) were enrolled. Data was obtained from medical records and pump data was downloaded for 30 days. Basal insulin, bolus calculator parameters, and PLGS operation parameters were analyzed and compared with Time in Range, Time Below Range, and Time Above Range. Results112 patients were included, with average TIR of 73,96 % and HbA1c 7,0 % and 25 months of follow-up. Basal insulin remained similar to initial doses, with an increase of 27 % for the Dawn phenomenon. The Carbohydrate ratio was slightly more aggressive. Insulin sensitivity was 17 % less stringent than initially programmed. No differences were observed in Time in Rage according to the number of basal, ratio, and sensitivity segments. Time of insulin suspension correlated directly with Time Bellow Range. ConclusionsPatients with good metabolic control have basal insulin programming similar to their initiation doses with less aggressive sensitivity factors. Excessive suspension time determined by PLGS could be an expression of excess insulin and increased hypoglycemia risk.

Outpatient Randomized Crossover Comparison of Zone Model Predictive Control Automated Insulin Delivery with Weekly Data Driven Adaptation Versus Sensor-Augmented Pump: Results from the International Diabetes Closed-Loop Trial 4.

Background: Automated insulin delivery (AID) systems have proven effective in increasing time-in-range during both clinical trials and real-world use. Further improvements in outcomes for single-hormone (insulin only) AID may be limited by suboptimal insulin delivery settings. Methods: Adults (≥18 years of age) with type 1 diabetes were randomized to either sensor-augmented pump (SAP) (inclusive of predictive low-glucose suspend) or adaptive zone model predictive control AID for 13 weeks, then crossed over to the other arm. Each week, the AID insulin delivery settings were sequentially and automatically updated by an adaptation system running on the study phone. Primary outcome was sensor glucose time-in-range 70-180 mg/dL, with noninferiority in percent time below 54 mg/dL as a hierarchical outcome. Results: Thirty-five participants completed the trial (mean age 39 ± 16 years, HbA1c at enrollment 6.9% ± 1.0%). Mean time-in-range 70-180 mg/dL was 66% with SAP versus 69% with AID (mean adjusted difference +2% [95% confidence interval: -1% to +6%], P = 0.22). Median time <70 mg/dL improved from 3.0% with SAP to 1.6% with AID (-1.5% [-2.4% to -0.5%], P = 0.002). The adaptation system decreased initial basal rates by a median of 4% (-8%, 16%) and increased initial carbohydrate ratios by a median of 45% (32%, 59%) after 13 weeks. Conclusions: Automated adaptation of insulin delivery settings with AID use did not significantly improve time-in-range in this very well-controlled population. Additional study and further refinement of the adaptation system are needed, especially in populations with differing degrees of baseline glycemic control, who may show larger benefits from adaptation.